Validation of a method for determination of amoxicillin residues applied to cleaning validation process in penicillins pharmaceutical industry

Quimica nova

Gomes, Maria Luiza Pinheiro Costa¹  Souza, Scheilla Vitorino Carvalho de¹ 

[1] Centro Universitário Newton Paiva, Belo Horizonte, Brasil

关键词: amoxicillin;    method validation;    cleaning validation.;   

DOI  :  10.1590/S0100-40422010000400038

学科分类：化学（综合）

来源: Sociedade Brasileira de Quimica

【 摘 要 】

The aim of thiswork was the single-laboratory validation of a quantitative method for the determinationof amoxicillin residues in support of cleaning control and validation. Linearitywas demonstrated between 2.5 and 17.5 μg/mL,without matrix effects. Mean recoveries ranged from 84.00 to 103.74% and therelative standard deviation under repetitivity and within-reproducibility conditionswere from 0.58 to 4.20% and from 0.79 to 4.39%, respectively. The theoreticallimits of detection and quantification were 0.133 and 0.442 μg/mL,respectively. The studied method was suitable for cleaning control purpose withingood manufacturing practices.

【 授权许可】

CC BY